Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer (DISRUPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01263886
First received: December 14, 2010
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

Primary Objective:

  • To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Secondary Objective:

  • To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: ombrabulin (AVE8062)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Objective response rate (OR) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVE8062 and combination

Day 1: AVE8062

Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: ombrabulin (AVE8062)

Pharmaceutical form:solution

Route of administration: intravenous

Placebo Comparator: Placebo

Day 1: placebo

Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: placebo

Pharmaceutical form:solution

Route of administration: intravenous


Detailed Description:

Patients will be treated for a maximum of 6 cycles (21 days each), in the absence of unacceptable toxicity or disease progression or consent withdrawal. All patients will be followed for disease progression documentation and for patient status until up to one year after the primary analysis cutoff date.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically proven squamous metastatic non-small cell lung cancer (stage IV, according to Tumor Nodes Metastasis (TNM) classification seventh edition)
  • Patients with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

  • Prior chemotherapy, immunotherapy or targeted therapy for lung cancer disease (including adjuvant/neoadjuvant therapy)
  • History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis
  • History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Acquired immunodeficiency syndrome (AIDS-related illness) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment
  • Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Patient with reproductive potential (Male/Female) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment
  • Inadequate organ function
  • Pre-existing peripheral neuropathy > grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.4.03
  • Pre-existing hearing impairment > grade 2
  • Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound of the study drug combination
  • Other serious illness or medical conditions such as (but not restricted): Active infection, Superior vena cava syndrome, Pericardial effusion requiring intervention (drainage)
  • Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thromboembolism within the past 6 months still requiring anticoagulants.
  • Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension.
  • Patient with Left Ventricular Ejection Fraction (LVEF) value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography
  • 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation ≥1 mm in at least 2 contiguous leads
  • History of gross hemoptysis (i.e. 1/2 teaspoon of red blood or more per episode) within the past 1 month.
  • Has non-squamous NSCLC(adenocarcinoma/large cell or other)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263886

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840001
Muscle Shoals, Alabama, United States, 35661
United States, Arkansas
Investigational Site Number 840003
Hot Springs, Arkansas, United States, 71913
United States, California
Investigational Site Number 840002
Anaheim, California, United States, 92801
Investigational Site Number 840009
Modesto, California, United States, 95355
United States, Michigan
Investigational Site Number 840005
Lansing, Michigan, United States, 48912
Australia
Investigational Site Number 036002
Bendigo, Australia, 3550
Investigational Site Number 036001
Southport, Australia, 4215
Chile
Investigational Site Number 152003
Santiago, Chile, 8380456
Investigational Site Number 152002
Santiago, Chile, 7510032
Investigational Site Number 152005
Santiago, Chile, 751-0009
Investigational Site Number 152004
Valparaiso, Chile, 2363058
Croatia
Investigational Site Number 191003
Zagreb, Croatia, 10000
Investigational Site Number 191001
Zagreb, Croatia
Investigational Site Number 191002
Zagreb, Croatia, 10000
France
Investigational Site Number 250005
Bordeaux Cedex, France, 33076
Investigational Site Number 250002
Dijon, France, 21034
Investigational Site Number 250003
Lyon, France, 69373
Investigational Site Number 250004
Nice Cedex 02, France, 06189
Investigational Site Number 250001
Saint-Herblain Cedex, France, 44805
Germany
Investigational Site Number 276001
Gauting, Germany, 82131
Investigational Site Number 276002
Großhansdorf, Germany, 22927
Investigational Site Number 276003
Immenhausen, Germany, 34376
Italy
Investigational Site Number 380002
Genova, Italy, 16132
Investigational Site Number 380003
Milano, Italy, 20132
Investigational Site Number 380001
Monza, Italy, 20052
Korea, Republic of
Investigational Site Number 410001
Seoul, Korea, Republic of, 135-710
Investigational Site Number 410003
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410002
Seoul, Korea, Republic of, 120-752
Poland
Investigational Site Number 616003
Lublin, Poland, 20-954
Investigational Site Number 616001
Poznan, Poland, 60-569
Investigational Site Number 616004
Warszawa, Poland, 02-781
Investigational Site Number 616005
Warszawa, Poland, 04-125
Romania
Investigational Site Number 642002
Bucharest, Romania, 050098
Investigational Site Number 642003
Cluj Napoca, Romania, 400015
Investigational Site Number 642004
Craiova, Romania, 200385
Investigational Site Number 642001
Iasi, Romania, 700106
Russian Federation
Investigational Site Number 643002
Moscow, Russian Federation, 115478
Investigational Site Number 643004
St-Petersburg, Russian Federation, 194291
Serbia
Investigational Site Number 688003
Belgrade, Serbia, 11080
Investigational Site Number 688001
Sremska Kamenica, Serbia, 21204
Ukraine
Investigational Site Number 804001
Dnipropetrovsk, Ukraine, 49102
Investigational Site Number 804003
Kyiv, Ukraine, 3022
Investigational Site Number 804002
Sumy, Ukraine, 40003
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01263886     History of Changes
Other Study ID Numbers: EFC10259, 2010-019384-11, U1111-1115-3677
Study First Received: December 14, 2010
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014